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A Phase 1b/2, Multicenter, Open-label, Dose-Finding Study to Evaluate the Safety and Antitumor Activity of Patritumab Deruxtecan in Participants with HER2 Positive Unresectable Locally Advanced Breast Cancer or Metastatic Breast Cancer.
Protocol: 042412Principal Investigator:
- Mridula A George
Applicable Disease Sites: Breast -
A Phase 1b/2, Multicenter, Open-label, Dose-Finding Study to Evaluate the Safety and Antitumor Activity of Patritumab Deruxtecan in Participants with HER2 Positive Unresectable Locally Advanced Breast Cancer or Metastatic Breast Cancer.
Protocol: 042412Principal Investigator:
- Mridula A George
Applicable Disease Sites: Breast -
A Phase 3 Open-label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant Versus Capivasertib + Fulvestrant as Treatment for PIK3CA-Mutant Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative
(HR+/HER2-) Locally Advanced or Metastatic Breast Cancer Following Recurrence or Progression On or After Treatment with a CDK4/6 Inhibitor.
Protocol: 042502Principal Investigator:
- Mridula A George
Applicable Disease Sites: Breast -
A Phase 3 Open-label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant Versus Capivasertib + Fulvestrant as Treatment for PIK3CA-Mutant Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative
(HR+/HER2-) Locally Advanced or Metastatic Breast Cancer Following Recurrence or Progression On or After Treatment with a CDK4/6 Inhibitor.
Protocol: 042502Principal Investigator:
- Mridula A George
Applicable Disease Sites: Breast -
Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin/Paclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk, Early-Stage, Triple-Negative Breast Cancer or Hormone Receptor-Low Positive/Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer.
Protocol: 042504Principal Investigator:
- Mridula A George
Applicable Disease Sites: Breast -
Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin/Paclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk, Early-Stage, Triple-Negative Breast Cancer or Hormone Receptor-Low Positive/Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer.
Protocol: 042504Principal Investigator:
- Mridula A George
Applicable Disease Sites: Breast -
A PHASE Ib/II MULTICENTER, OPEN-LABEL, RANDOMIZED STUDY EVALUATING THE SAFETY, PHARMACOKINETICS, AND ACTIVITY OF GDC-4198 ALONE AND IN COMBINATION WITH GIREDESTRANT IN COMPARISON WITH ABEMACICLIB AND GIREDESTRANT IN PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE BREAST CANCER WHO HAVE PREVIOUSLY PROGRESSED DURING OR AFTER A CDK4/6 INHIBITOR
Protocol: 042505Principal Investigator:
- Mridula A George
Applicable Disease Sites: Breast -
A PHASE Ib/II MULTICENTER, OPEN-LABEL, RANDOMIZED STUDY EVALUATING THE SAFETY, PHARMACOKINETICS, AND ACTIVITY OF GDC-4198 ALONE AND IN COMBINATION WITH GIREDESTRANT IN COMPARISON WITH ABEMACICLIB AND GIREDESTRANT IN PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE BREAST CANCER WHO HAVE PREVIOUSLY PROGRESSED DURING OR AFTER A CDK4/6 INHIBITOR
Protocol: 042505Principal Investigator:
- Mridula A George
Applicable Disease Sites: Breast -
Phase 2 Study to Optimize Neoadjuvant Therapy in HER2-Positive Early-Stage Breast Cancer Using ctDNA and HARPS Biomarker Assay.
Protocol: 042507Principal Investigator:
- Mridula A George
Applicable Disease Sites: Breast -
Phase 2 Study to Optimize Neoadjuvant Therapy in HER2-Positive Early-Stage Breast Cancer Using ctDNA and HARPS Biomarker Assay.
Protocol: 042507Principal Investigator:
- Mridula A George
Applicable Disease Sites: Breast -
A Phase III, Multisite, Randomized, Double-Blind Trial of BNT327 in Combination with Chemotherapy versus Placebo with Chemotherapy in Patients with Previously Untreated Locally Recurrent Inoperable or Metastatic TNBC Determined Ineligible for PD(L)1 Therapy Based on PD-L1 Negative Disease.
Protocol: 042601Principal Investigator:
- Mridula A George
Applicable Disease Sites: Breast -
A Phase III, Multisite, Randomized, Double-Blind Trial of BNT327 in Combination with Chemotherapy versus Placebo with Chemotherapy in Patients with Previously Untreated Locally Recurrent Inoperable or Metastatic TNBC Determined Ineligible for PD(L)1 Therapy Based on PD-L1 Negative Disease.
Protocol: 042601Principal Investigator:
- Mridula A George
Applicable Disease Sites: Breast -
A First-in-Human, Open-Label, Dose Escalation and Expansion Trial of BTX-9341 in Participants with Advanced and/or Metastatic Breast Cancer
Protocol: 042602Principal Investigator:
- Mridula A George
Applicable Disease Sites: Breast -
A First-in-Human, Open-Label, Dose Escalation and Expansion Trial of BTX-9341 in Participants with Advanced and/or Metastatic Breast Cancer
Protocol: 042602Principal Investigator:
- Mridula A George
Applicable Disease Sites: Breast -
SHORTened duration of TAMoxifen for risk reduction in breast intraepithelial neoplasms in post-menopausal women.
Protocol: 042606Principal Investigator:
- Mridula A George
Applicable Disease Sites: Breast -
SHORTened duration of TAMoxifen for risk reduction in breast intraepithelial neoplasms in post-menopausal women.
Protocol: 042606Principal Investigator:
- Mridula A George
Applicable Disease Sites: Breast